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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(MARK ONE)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number 001-35238

 

HORIZON THERAPEUTICS PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

 

Ireland

 

Not Applicable

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

70 Saint Stephen’s Green

Dublin 2, D02 E2X4, Ireland

 

Not Applicable

(Address of principal executive offices)

 

(Zip Code)

011 353 1 772 2100

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Ordinary shares, nominal value $0.0001 per share

HZNP

The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.  See the definitions of ‘‘large accelerated filer,’’ ‘‘accelerated filer,’’ ‘‘smaller reporting company,’’ and ‘‘emerging growth company’’ in Rule 12b–2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

  

Smaller reporting company

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

Number of registrant’s ordinary shares, nominal value $0.0001, outstanding as of October 28, 2021: 226,821,014

 


 

HORIZON THERAPEUTICS PLC

INDEX

 

 

 

 

 

Page

 

 

 

No.

PART I. FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements

 

1

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and as of December 31, 2020 (Unaudited)

 

1

 

Condensed Consolidated Statements of Comprehensive Income for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

2

 

Condensed Consolidated Statements of Shareholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

3

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

35

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

57

Item 4.

Controls and Procedures

 

58

PART II. OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

 

59

Item 1A.

Risk Factors

 

59

Item 6.

Exhibits

 

115

 

Signatures

 

117

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

HORIZON THERAPEUTICS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except nominal value and share data)

 

 

As of

 

As of

 

 

September 30,

 

December 31,

 

 

2021

 

2020

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

$

1,068,547

 

$

2,079,906

 

Restricted cash

 

3,839

 

 

3,573

 

Accounts receivable, net

 

775,371

 

 

659,701

 

Inventories, net

 

237,434

 

 

75,283

 

Prepaid expenses and other current assets

 

328,730

 

 

251,945

 

Total current assets

 

2,413,921

 

 

3,070,408

 

Property, plant and equipment, net

 

285,837

 

 

189,037

 

Developed technology and other intangible assets, net

 

3,051,135

 

 

1,782,962

 

In-process research and development

 

880,000

 

 

 

Goodwill

 

1,069,031

 

 

413,669

 

Deferred tax assets, net

 

782,852

 

 

560,841

 

Other assets

 

125,912

 

 

55,699

 

Total assets

$

8,608,688

 

$

6,072,616

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

$

50,724

 

$

37,710

 

Accrued expenses and other current liabilities

 

483,833

 

 

485,567

 

Accrued trade discounts and rebates

 

303,486

 

 

352,463

 

Long-term debt—current portion

 

16,000

 

 

 

Total current liabilities

 

854,043

 

 

875,740

 

LONG-TERM LIABILITIES:

 

 

 

 

 

 

Long-term debt, net

 

2,557,864

 

 

1,003,379

 

Deferred tax liabilities, net

 

591,552

 

 

66,474

 

Other long-term liabilities

 

155,015

 

 

101,672

 

Total long-term liabilities

 

3,304,431

 

 

1,171,525

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

SHAREHOLDERS’ EQUITY:

 

 

 

 

 

 

Ordinary shares, $0.0001 nominal value; 600,000,000 shares authorized at September 30, 2021 and December 31, 2020; 227,026,047 and 221,721,674 shares issued at September 30, 2021 and December 31, 2020, respectively, and 226,641,681 and 221,337,308 shares outstanding at September 30, 2021 and December 31, 2020, respectively

 

22

 

 

22

 

Treasury stock, 384,366 ordinary shares at September 30, 2021 and December 31, 2020

 

(4,585

)

 

(4,585

)

Additional paid-in capital

 

4,310,886

 

 

4,245,945

 

Accumulated other comprehensive loss

 

(1,532

)

 

(145

)

Retained earnings (accumulated deficit)

 

145,423

 

 

(215,886

)

Total shareholders’ equity

 

4,450,214

 

 

4,025,351

 

Total liabilities and shareholders' equity

$

8,608,688

 

$

6,072,616

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


 

HORIZON THERAPEUTICS PLC

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(UNAUDITED)

(In thousands, except share and per share data)

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

Net sales

$

1,036,992

 

 

$

636,427

 

 

$

2,211,946

 

 

$

1,455,115

 

 

Cost of goods sold

 

251,640

 

 

 

151,475

 

 

 

553,003

 

 

 

370,406

 

 

Gross profit

 

785,352

 

 

 

484,952

 

 

 

1,658,943

 

 

 

1,084,709

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

93,549

 

 

 

30,206

 

 

 

291,076

 

 

 

138,483

 

 

Selling, general and administrative

 

360,260

 

 

 

226,164

 

 

 

1,047,456

 

 

 

696,271

 

 

Impairment of long-lived asset

 

 

 

 

 

 

 

12,371

 

 

 

 

 

Gain on sale of asset

 

 

 

 

 

 

 

(2,000

)

 

 

 

 

Total operating expenses

 

453,809

 

 

 

256,370

 

 

 

1,348,903

 

 

 

834,754

 

 

Operating income

 

331,543

 

 

 

228,582

 

 

 

310,040

 

 

 

249,955

 

 

OTHER EXPENSE, NET:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

(22,977

)

 

 

(12,185

)

 

 

(59,018

)

 

 

(48,100

)

 

Foreign exchange (loss) gain

 

(476

)

 

 

(753

)

 

 

(1,363

)

 

 

306

 

 

Loss on debt extinguishment

 

 

 

 

(14,602

)

 

 

 

 

 

(31,856

)

 

Other (expense) income, net

 

(849

)

 

 

717

 

 

 

2,113

 

 

 

1,791

 

 

Total other expense, net

 

(24,302

)

 

 

(26,823

)

 

 

(58,268

)

 

 

(77,859

)

 

Income before benefit for income taxes

 

307,241

 

 

 

201,759

 

 

 

251,772

 

 

 

172,096

 

 

Benefit for income taxes

 

(19,302

)

 

 

(91,081

)

 

 

(109,537

)

 

 

(27,143

)

 

Net income

$

326,543

 

 

$

292,840

 

 

$

361,309

 

 

$

199,239

 

 

Net income per ordinary share—basic

$

1.44

 

 

$

1.38

 

 

$

1.61

 

 

$

1.00

 

 

Weighted average ordinary shares outstanding—basic

 

226,096,747

 

 

 

212,320,219

 

 

 

225,053,704

 

 

 

198,413,779

 

 

Net income per ordinary share—diluted

$

1.38

 

 

$

1.31

 

 

$

1.54

 

 

$

0.95

 

 

Weighted average ordinary shares outstanding—diluted

 

236,198,789

 

 

 

223,743,903

 

 

 

235,256,424

 

 

 

208,678,460

 

 

OTHER COMPREHENSIVE (LOSS) INCOME, NET OF TAX

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

$

(514

)

 

$

858

 

 

$

(1,100

)

 

$

877

 

 

Pension remeasurements

 

 

 

 

 

 

 

(287

)

 

 

 

 

Other comprehensive (loss) income

 

(514

)

 

 

858

 

 

 

(1,387

)

 

 

877

 

 

Comprehensive income

$

326,029

 

 

$

293,698

 

 

$

359,922

 

 

$

200,116

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

2


 

 

HORIZON THERAPEUTICS PLC

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(UNAUDITED)

(In thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated Other

 

 

Retained Earnings

 

 

Total

 

 

 

Ordinary Shares

 

 

Treasury Stock

 

 

Paid-in

 

 

Comprehensive

 

 

(Accumulated

 

 

Shareholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit)

 

 

Equity

 

Balances at December 31, 2020

 

 

221,721,674

 

 

$

22

 

 

 

384,366

 

 

$

(4,585

)

 

$

4,245,945

 

 

$

(145

)

 

$

(215,886

)

 

$

4,025,351

 

Issuance of ordinary shares in conjunction with the exercise of stock options

and the vesting of restricted stock and performance stock units

 

 

3,305,947

 

 

 

 

 

 

 

 

 

 

 

 

19,843

 

 

 

 

 

 

 

 

 

19,843

 

Ordinary shares withheld for payment of employees’ withholding tax liability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(128,261

)

 

 

 

 

 

 

 

 

(128,261

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

62,296

 

 

 

 

 

 

 

 

 

62,296

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(821

)

 

 

 

 

 

(821

)

Pension remeasurements

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(287

)

 

 

 

 

 

(287

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(123,351

)

 

 

(123,351

)

Balances at March 31, 2021

 

 

225,027,621

 

 

$

22

 

 

 

384,366

 

 

$

(4,585

)

 

$

4,199,823

 

 

$

(1,253

)

 

$

(339,237

)

 

$

3,854,770

 

Issuance of ordinary shares in conjunction with the exercise of stock options

and the vesting of restricted stock and performance stock units

 

 

597,169

 

 

 

 

 

 

 

 

 

 

 

 

7,996

 

 

 

 

 

 

 

 

 

7,996

 

Issuance of ordinary shares in conjunction with Employee Share Purchase Plan

 

 

474,997

 

 

 

 

 

 

 

 

 

 

 

 

11,482

 

 

 

 

 

 

 

 

 

11,482

 

Ordinary shares withheld for payment of employees’ withholding tax liability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,388

)

 

 

 

 

 

 

 

 

(13,388

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

54,424

 

 

 

 

 

 

 

 

 

54,424

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

235

 

 

 

 

 

 

235

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

158,117

 

 

 

158,117

 

Balances at June 30, 2021

 

 

226,099,787

 

 

$

22

 

 

 

384,366

 

 

$

(4,585

)

 

$

4,260,337

 

 

$

(1,018

)

 

$

(181,120

)

 

$

4,073,636

 

Issuance of ordinary shares in conjunction with the exercise of stock options

and the vesting of restricted stock and performance stock units

 

 

926,260

 

 

 

 

 

 

 

 

 

 

 

 

12,173

 

 

 

 

 

 

 

 

 

12,173

 

Ordinary shares withheld for payment of employees’ withholding tax liability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,428

)

 

 

 

 

 

 

 

 

(16,428

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

54,804

 

 

 

 

 

 

 

 

 

54,804

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(514

)

 

 

 

 

 

(514

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

326,543

 

 

 

326,543

 

Balances at September 30, 2021

 

 

227,026,047

 

 

$

22

 

 

 

384,366

 

 

$

(4,585

)

 

$

4,310,886

 

 

$

(1,532

)

 

$

145,423

 

 

$

4,450,214

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


HORIZON THERAPEUTI